Prioritization and Timing of Outcomes and Endpoints After Aneurysmal Subarachnoid Hemorrhage in Clinical Trials and Observational Studies: Proposal of a Multidisciplinary Research Group
Introduction In studies on aneurysmal subarachnoid hemorrhage (SAH), substantial variability exists in the use and timing of outcomes and endpoints, which complicates interpretation and comparison of results between studies. The aim of the National Institute of Health/National Institute of Neurologi...
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| Published in: | Neurocritical care Vol. 30; no. Suppl 1; pp. 102 - 113 |
|---|---|
| Main Authors: | , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
New York
Springer US
01.06.2019
Springer Nature B.V |
| Subjects: | |
| ISSN: | 1541-6933, 1556-0961, 1556-0961 |
| Online Access: | Get full text |
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| Abstract | Introduction
In studies on aneurysmal subarachnoid hemorrhage (SAH), substantial variability exists in the use and timing of outcomes and endpoints, which complicates interpretation and comparison of results between studies. The aim of the National Institute of Health/National Institute of Neurological Disorders and Stroke/National Library of Medicine Unruptured Intracranial Aneurysm (UIA) and SAH common data elements (CDE) Project was to provide a common structure for future UIA and SAH research.
Methods
This article summarizes the recommendations of the UIA and SAH CDE Outcomes and Endpoints subgroup, which consisted of an international and multidisciplinary ad hoc panel of experts in clinical outcomes after SAH. Consensus recommendations were developed by review of previously published CDEs for other neurological diseases and the SAH literature. Recommendations for CDEs were classified by priority into “Core,” “Supplemental—Highly Recommended,” “Supplemental,” and “Exploratory.”
Results
The subgroup identified over 50 outcomes measures and template case report forms (CRFs) to be included as part of the UIA and SAH CDE recommendations. None was classified as “Core”. The modified Rankin Scale score and Montreal Cognitive Assessment were considered the preferred outcomes and classified as Supplemental—Highly Recommended. Death, Glasgow Outcome Scale score, and Glasgow Outcome Scale-extended were classified as Supplemental. All other outcome measures were categorized as “Exploratory”. We propose outcome assessment at 3 months and at 12 months for studies interested in long-term outcomes. We give recommendations for standardized dichotomization.
Conclusion
The recommended outcome measures and CRFs have been distilled from a broad pool of potentially useful CDEs, scales, instruments, and endpoints. The adherence to these recommendations will facilitate the comparison of results across studies and meta-analyses of individual patient data. |
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| AbstractList | In studies on aneurysmal subarachnoid hemorrhage (SAH), substantial variability exists in the use and timing of outcomes and endpoints, which complicates interpretation and comparison of results between studies. The aim of the National Institute of Health/National Institute of Neurological Disorders and Stroke/National Library of Medicine Unruptured Intracranial Aneurysm (UIA) and SAH common data elements (CDE) Project was to provide a common structure for future UIA and SAH research.INTRODUCTIONIn studies on aneurysmal subarachnoid hemorrhage (SAH), substantial variability exists in the use and timing of outcomes and endpoints, which complicates interpretation and comparison of results between studies. The aim of the National Institute of Health/National Institute of Neurological Disorders and Stroke/National Library of Medicine Unruptured Intracranial Aneurysm (UIA) and SAH common data elements (CDE) Project was to provide a common structure for future UIA and SAH research.This article summarizes the recommendations of the UIA and SAH CDE Outcomes and Endpoints subgroup, which consisted of an international and multidisciplinary ad hoc panel of experts in clinical outcomes after SAH. Consensus recommendations were developed by review of previously published CDEs for other neurological diseases and the SAH literature. Recommendations for CDEs were classified by priority into "Core," "Supplemental-Highly Recommended," "Supplemental," and "Exploratory."METHODSThis article summarizes the recommendations of the UIA and SAH CDE Outcomes and Endpoints subgroup, which consisted of an international and multidisciplinary ad hoc panel of experts in clinical outcomes after SAH. Consensus recommendations were developed by review of previously published CDEs for other neurological diseases and the SAH literature. Recommendations for CDEs were classified by priority into "Core," "Supplemental-Highly Recommended," "Supplemental," and "Exploratory."The subgroup identified over 50 outcomes measures and template case report forms (CRFs) to be included as part of the UIA and SAH CDE recommendations. None was classified as "Core". The modified Rankin Scale score and Montreal Cognitive Assessment were considered the preferred outcomes and classified as Supplemental-Highly Recommended. Death, Glasgow Outcome Scale score, and Glasgow Outcome Scale-extended were classified as Supplemental. All other outcome measures were categorized as "Exploratory". We propose outcome assessment at 3 months and at 12 months for studies interested in long-term outcomes. We give recommendations for standardized dichotomization.RESULTSThe subgroup identified over 50 outcomes measures and template case report forms (CRFs) to be included as part of the UIA and SAH CDE recommendations. None was classified as "Core". The modified Rankin Scale score and Montreal Cognitive Assessment were considered the preferred outcomes and classified as Supplemental-Highly Recommended. Death, Glasgow Outcome Scale score, and Glasgow Outcome Scale-extended were classified as Supplemental. All other outcome measures were categorized as "Exploratory". We propose outcome assessment at 3 months and at 12 months for studies interested in long-term outcomes. We give recommendations for standardized dichotomization.The recommended outcome measures and CRFs have been distilled from a broad pool of potentially useful CDEs, scales, instruments, and endpoints. The adherence to these recommendations will facilitate the comparison of results across studies and meta-analyses of individual patient data.CONCLUSIONThe recommended outcome measures and CRFs have been distilled from a broad pool of potentially useful CDEs, scales, instruments, and endpoints. The adherence to these recommendations will facilitate the comparison of results across studies and meta-analyses of individual patient data. IntroductionIn studies on aneurysmal subarachnoid hemorrhage (SAH), substantial variability exists in the use and timing of outcomes and endpoints, which complicates interpretation and comparison of results between studies. The aim of the National Institute of Health/National Institute of Neurological Disorders and Stroke/National Library of Medicine Unruptured Intracranial Aneurysm (UIA) and SAH common data elements (CDE) Project was to provide a common structure for future UIA and SAH research.MethodsThis article summarizes the recommendations of the UIA and SAH CDE Outcomes and Endpoints subgroup, which consisted of an international and multidisciplinary ad hoc panel of experts in clinical outcomes after SAH. Consensus recommendations were developed by review of previously published CDEs for other neurological diseases and the SAH literature. Recommendations for CDEs were classified by priority into “Core,” “Supplemental—Highly Recommended,” “Supplemental,” and “Exploratory.”ResultsThe subgroup identified over 50 outcomes measures and template case report forms (CRFs) to be included as part of the UIA and SAH CDE recommendations. None was classified as “Core”. The modified Rankin Scale score and Montreal Cognitive Assessment were considered the preferred outcomes and classified as Supplemental—Highly Recommended. Death, Glasgow Outcome Scale score, and Glasgow Outcome Scale-extended were classified as Supplemental. All other outcome measures were categorized as “Exploratory”. We propose outcome assessment at 3 months and at 12 months for studies interested in long-term outcomes. We give recommendations for standardized dichotomization.ConclusionThe recommended outcome measures and CRFs have been distilled from a broad pool of potentially useful CDEs, scales, instruments, and endpoints. The adherence to these recommendations will facilitate the comparison of results across studies and meta-analyses of individual patient data. Introduction In studies on aneurysmal subarachnoid hemorrhage (SAH), substantial variability exists in the use and timing of outcomes and endpoints, which complicates interpretation and comparison of results between studies. The aim of the National Institute of Health/National Institute of Neurological Disorders and Stroke/National Library of Medicine Unruptured Intracranial Aneurysm (UIA) and SAH common data elements (CDE) Project was to provide a common structure for future UIA and SAH research. Methods This article summarizes the recommendations of the UIA and SAH CDE Outcomes and Endpoints subgroup, which consisted of an international and multidisciplinary ad hoc panel of experts in clinical outcomes after SAH. Consensus recommendations were developed by review of previously published CDEs for other neurological diseases and the SAH literature. Recommendations for CDEs were classified by priority into “Core,” “Supplemental—Highly Recommended,” “Supplemental,” and “Exploratory.” Results The subgroup identified over 50 outcomes measures and template case report forms (CRFs) to be included as part of the UIA and SAH CDE recommendations. None was classified as “Core”. The modified Rankin Scale score and Montreal Cognitive Assessment were considered the preferred outcomes and classified as Supplemental—Highly Recommended. Death, Glasgow Outcome Scale score, and Glasgow Outcome Scale-extended were classified as Supplemental. All other outcome measures were categorized as “Exploratory”. We propose outcome assessment at 3 months and at 12 months for studies interested in long-term outcomes. We give recommendations for standardized dichotomization. Conclusion The recommended outcome measures and CRFs have been distilled from a broad pool of potentially useful CDEs, scales, instruments, and endpoints. The adherence to these recommendations will facilitate the comparison of results across studies and meta-analyses of individual patient data. In studies on aneurysmal subarachnoid hemorrhage (SAH), substantial variability exists in the use and timing of outcomes and endpoints, which complicates interpretation and comparison of results between studies. The aim of the National Institute of Health/National Institute of Neurological Disorders and Stroke/National Library of Medicine Unruptured Intracranial Aneurysm (UIA) and SAH common data elements (CDE) Project was to provide a common structure for future UIA and SAH research. This article summarizes the recommendations of the UIA and SAH CDE Outcomes and Endpoints subgroup, which consisted of an international and multidisciplinary ad hoc panel of experts in clinical outcomes after SAH. Consensus recommendations were developed by review of previously published CDEs for other neurological diseases and the SAH literature. Recommendations for CDEs were classified by priority into "Core," "Supplemental-Highly Recommended," "Supplemental," and "Exploratory." The subgroup identified over 50 outcomes measures and template case report forms (CRFs) to be included as part of the UIA and SAH CDE recommendations. None was classified as "Core". The modified Rankin Scale score and Montreal Cognitive Assessment were considered the preferred outcomes and classified as Supplemental-Highly Recommended. Death, Glasgow Outcome Scale score, and Glasgow Outcome Scale-extended were classified as Supplemental. All other outcome measures were categorized as "Exploratory". We propose outcome assessment at 3 months and at 12 months for studies interested in long-term outcomes. We give recommendations for standardized dichotomization. The recommended outcome measures and CRFs have been distilled from a broad pool of potentially useful CDEs, scales, instruments, and endpoints. The adherence to these recommendations will facilitate the comparison of results across studies and meta-analyses of individual patient data. |
| Author | Visser-Meily, Johanna M. Hänggi, Daniel Stienen, Martin N. Schweizer, Tom A. Vergouwen, Mervyn D. I. Macdonald, R. Loch |
| Author_xml | – sequence: 1 givenname: Martin N. orcidid: 0000-0003-0548-9936 surname: Stienen fullname: Stienen, Martin N. email: mnstienen@gmail.com organization: Department of Neurosurgery, UniversitätsSpital Zürich, Clinical Neuroscience Center, University of Zurich – sequence: 2 givenname: Johanna M. surname: Visser-Meily fullname: Visser-Meily, Johanna M. organization: Department of Rehabilitation, Physical Therapy Science and Sports, Brain Center Rudolf Magnus, University Medical Center Utrecht – sequence: 3 givenname: Tom A. surname: Schweizer fullname: Schweizer, Tom A. organization: Division of Neurosurgery, Department of Surgery, St. Michael’s Hospital, Labatt Family Centre of Excellence in Brain Injury and Trauma Research, Keenan Research Centre for Biomedical Research and Li Ka Shing Knowledge Institute, University of Toronto – sequence: 4 givenname: Daniel surname: Hänggi fullname: Hänggi, Daniel organization: Department of Neurosurgery, University Medical Center Mannheim, Ruprecht-Karls-University Heidelberg – sequence: 5 givenname: R. Loch surname: Macdonald fullname: Macdonald, R. Loch organization: Division of Neurosurgery, Department of Surgery, St. Michael’s Hospital, Labatt Family Centre of Excellence in Brain Injury and Trauma Research, Keenan Research Centre for Biomedical Research and Li Ka Shing Knowledge Institute, University of Toronto – sequence: 6 givenname: Mervyn D. I. surname: Vergouwen fullname: Vergouwen, Mervyn D. I. organization: Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus, University Medical Center Utrecht |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/31123994$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Contributor | Macdonald, R Loch Damani, Rahul Kelly, Adam Murayama, Yuuichi Amin-Hanjani, Sepideh Stienen, Martin N Moy, Claudia Bulsara, Ketan Joseph, Kristen Nyquist, Paul Langer, David J Juvela, Seppo Nakaji, Peter Vespa, Paul M Mocco, J Daly, Janis Wintermark, Max Morita, Akio Amos, Liz Keller, Emanuela Sarrafzadeh-Khorrasani, Asita Simone Algra, Ale McDougall, Cameron G Rabinstein, Alejandro Hackenberg, Katharina de Oliveira Manoel, Airton Leonardo Bijlenga, Philippe Vajkoczy, Peter Rüfenacht, Daniel Hoh, Brian L Alan Hoffer, S Derdeyn, Colin P Krings, Timo Torner, James Hänggi, Daniel Olson, Daiwai Huston, 3rd, John Dhar, Raj Woo, Henry Meyers, Philip M Gunel, Murat Hasan, David LeRoux, Peter D Etminan, Nima Kirkpatrick, Peter J Ko, Nerissa Chou, Sherry Mayer, Stephan Zipfel, Gregory J Werner, Marieke J H Kasuya, Hidetoshi Roederer, Alexander Ala'i, Sherita Mutoh, Tatsushi Odenkirchen, Joanne Rinkel, Gabriel Vergouwen, Mervyn D I Doré, Sylvain Ruigrok, Ynte Bambakidis, Nicholas Brown, Jr, Robert D Sheikh, Muniza Holloway, Robert G Muehlschlegel, Susanne Lu |
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| Copyright | Neurocritical Care Society 2019 Neurocritical Care Society 2019. |
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| DOI | 10.1007/s12028-019-00737-0 |
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| Keywords | Montreal Cognitive Assessment MoCA Subarachnoid hemorrhage Hemorrhagic stroke Aneurysm Standardization Data coding Outcomes mRS Endpoints Common data elements Modified Rankin Scale Data collection Clinical studies |
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In studies on aneurysmal subarachnoid hemorrhage (SAH), substantial variability exists in the use and timing of outcomes and endpoints, which... In studies on aneurysmal subarachnoid hemorrhage (SAH), substantial variability exists in the use and timing of outcomes and endpoints, which complicates... IntroductionIn studies on aneurysmal subarachnoid hemorrhage (SAH), substantial variability exists in the use and timing of outcomes and endpoints, which... |
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| SubjectTerms | Aneurysm, Ruptured - therapy Aneurysms Biomedical Research Classification Clinical trials Clinical Trials as Topic Common Data Elements Critical Care Medicine Disease Fatalities Generalized anxiety disorder Humans Intensive Internal Medicine Intracranial Aneurysm - therapy Medical prognosis Medicine Medicine & Public Health Memory National Institute of Neurological Disorders and Stroke (U.S.) National Library of Medicine (U.S.) Neurological disorders Neurology Neuropsychology Observational studies Observational Studies as Topic Outcome Assessment, Health Care Post traumatic stress disorder Quality of life Questionnaires Special Article Stroke Subarachnoid Hemorrhage - therapy Time Factors United States |
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| Title | Prioritization and Timing of Outcomes and Endpoints After Aneurysmal Subarachnoid Hemorrhage in Clinical Trials and Observational Studies: Proposal of a Multidisciplinary Research Group |
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